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NCT Number: NCT02503215

Effects of Compression Stockings on Obstructive Sleep Apnea in Patients Under Hemodialysis

To study the effects of compression stockings on sleep apnea in hemodialysis patients with diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper airways edema.

The aim of this study is to evaluate if compression stockings could improve such nocturnal volume redistribution and, therefore, improve obstructive sleep apnea.

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Key information

Conditions

Renal Failure Chronic Requiring Dialysis Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas 05302050

São Paulo, 05403-000, Brazil

About this study

Investigators will apply the following methods:

  • Sleep study, performed through polysomnography
  • Fluid redistribution, by bioimpedance analysis
  • Autonomic nervous system evaluation, by spectral heart rate variability analysis.

The study protocol comprises two moments: baseline evaluation (in patients with diagnosed sleep apnea) and after using compression stockings for a one-week period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients under hemodialysis
  • Patients with diagnosed obstructive sleep apnea

Exclusion criteria

  • Congestive heart failure
  • Urine output > 500 ml/day
  • non-sinusal cardiac rhythm
  • refusal to give written consent

Treatment and study plan

compression stockings

Device

To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea

Primary outcomes

  1. Change of Obstructive Apnea Severity Index Score From Baseline

    Time frame: 1 week

    Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles):

    • AIH at baseline: 20.8 (14.2; 39.6) events/hour;
    • AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour

Secondary outcomes

  1. Change of Heart Rate Variability Change From Baseline

    Time frame: 1 week

    Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.

  2. Change in Fluid Distribution From Baseline

    Time frame: 1 week

    Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis

Acronym: EComStockOSA

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 20, 2015
Registry last updated
Jul 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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